Evaluating Chinese Medicine for Girls with Rapid Early Puberty
Official title: Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Run by Children's Hospital of Fudan University · NCT06820931 · Data updated 2026-11-12
This study is testing a traditional Chinese medicine to see if it can help girls who are going through puberty too quickly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years to 9 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06820931 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are girls aged 8 to 9 years with specific clinical signs of early puberty and good compliance.
✕Probably not a fit
Patients with disorders of gonadal development or those who have undergone treatments affecting gonadal function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of a traditional Chinese medicine formulation, Xuandi Ziyin Mixture, in treating girls experiencing rapid progression of early puberty. It will evaluate the differential expression of specific hormones before and after diagnosis to predict the rapid progression type. The study seeks to establish standardized clinical guidelines for diagnosing and treating this condition using traditional Chinese medicine. Participants will be closely monitored for compliance and therapeutic outcomes.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for girls with rapid early puberty, potentially improving their health outcomes.
How similar studies have gone: While traditional Chinese medicine approaches have been explored, this specific intervention and its efficacy in this context are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Girls with an onset age \>8 years and ≤9 years; * Breast bud Tanner stage II breast bud diameter \<3 cm; * Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm; * Bone age does not exceed actual age by more than 1 year; * LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L. * Good compliance; * Patients and their parents are willing to actively cooperate with the clinical trial; * Legal guardian signs the informed consent form. Exclusion Criteria: * Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.; * Use of treatments that affect gonadal function such as chemotherapy radiotherapy; * Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Wen Sun
- Email: sunwenhere@163.com
- Phone: 8613818844692
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.